Description and Brand Names

US Brand Name

Keppra

Keppra XR

Descriptions

Levetiracetam is used to help control certain types of seizures in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to use it.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Tablet, Extended Release

Tablet

Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of levetiracetam oral solution or tablets in children younger than 1 month of age, and levetiracetam extended-release tablets in children younger than 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levetiracetam in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving levetiracetam.

Pregnancy

Information about this levetiracetam-oral-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ketorolac

Methotrexate

Orlistat

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Carbamazepine

Ginkgo

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Depression, history of or

Mental illness, history of—Use with caution. May make these conditions worse.

Kidney problems—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine only as directed by your doctor, to help your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not change your dose without checking first with your doctor.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Levetiracetam may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed. You should try to take this medicine at the same time each day.

Swallow the tablet or the extended-release tablet whole. Do not break, crush, or chew it. There is an oral liquid form of this medicine if you or your child cannot swallow the tablets.

Measure the oral liquid with a marked measuring spoon, dropper, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. If you have any questions about this, ask your doctor or pharmacist.

This medicine can be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.

Take only the form of this medicine that your doctor prescribed. If you refill your prescription and your pills look different, do not take the medicine and tell your doctor or pharmacist right away.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (extended-release tablets):

For partial onset seizures:

Adults and children 16 years of age and older—At first, 1000 milligrams (mg) once a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 3000 mg per day.

Children younger than 16 years of age—Use and dose must be determined by your doctor.

For oral dosage forms (solution or tablets):

For partial onset seizures:

Adults and children 16 years of age and older—At first, 500 milligrams (mg) two times a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 3000 mg per day.

Children 4 to 15 years of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 milligram (mg) per kilogram (kg) of body weight two times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 60 mg per kg of body weight per day (ie, 30 mg per kg of body weight twice a day).

Children 6 months to 3 years of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 mg per kg of body weight two times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 50 mg per kg of body weight per day (ie, 25 mg per kg of body weight twice a day).

Children 1 to 5 months of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 7 mg per kg of body weight two times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 42 mg per kg of body weight per day (ie, 21 mg per kg of body weight twice a day).

Children younger than 1 month of age—Use and dose must be determined by your doctor.

For juvenile myoclonic seizures:

Children 12 years of age and older—At first, 500 milligrams (mg) two times a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 3000 mg per day.

Children younger than 12 years of age—Use and dose must be determined by your doctor.

For primary generalized tonic-clonic seizures:

Adults and children 16 years of age and older—At first, 500 milligrams (mg) two times a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 3000 mg per day.

Children 6 to 15 years of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 milligram (mg) per kilogram (kg) of body weight two times a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 60 mg per kg of body weight per day (ie, 30 mg per kg of body weight twice a day).

Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your or your child's progress at regular visits, especially for the first few months you or your child are taking this medicine. This is necessary to allow dose adjustments and to reduce any unwanted effects.

Levetiracetam may cause changes in mood or behavior, problems with coordination, or unusual tiredness or weakness. Tell your doctor right away if you or your child start to feel depressed, anxious, angry, getting upset easily, restless, or have thoughts about hurting yourself. Report any unusual thoughts or behavior that trouble you, especially if they are new or getting worse quickly.

This medicine may cause some people to become dizzy, drowsy, tired, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Do not stop taking levetiracetam without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

uncontrolled jerking or twisting movements of the hands, arms, or legs

uncontrolled movements of the lips, tongue, or cheeks

unexplained bleeding or bruising

unusual bleeding or bruising

upper right abdominal or stomach pain

weight loss

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Loss of strength or energy

muscle pain or weakness

pain

tender, swollen glands in the neck

trouble swallowing

unusual weak feeling

voice changes

Less common

Body aches or pain

burning, dry, or itching eyes

change in the color of the skin

congestion

cough increased

rash

sneezing

Incidence not known

Hair loss or thinning of the hair

skin rash, encrusted, scaly, and oozing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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